Topiramate vs. Placebo in Preventing Weight Gain in Bipolar Disorder Treated With Olanzapine

NCT00394095 | Completed Phase 4 Results DMC

• 1 other identifier: F1D-MC-X304
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study is to examine the efficacy of topiramate in combination with olanzapine for the prevention of weight gain in youth with bipolar disorder. The secondary objective is to examine the tolerability of topiramate in combination with olanzapine for the prevention of weight gain in youth with bipolar disorder.

Conditions

Bipolar Disorder; Weight Gain

Keywords

Bipolar Disorder; Weight Gain

Outcome Measures

Primary Outcomes (2)

• Change in Body Mass Index (BMI)

  For all participants, BMI was computed using Change in BMI \[kg/m2 (weight/height2)\] over 12 weeks from Baseline to Week 12.

  12 weeks

• Change in Body Weight

  For all participants, change in body weight in kg over 12 weeks from Baseline to Week 12.

  12 weeks

Secondary Outcomes (1)

• Tolerability of Topiramate

  12 weeks

Study Arms (2)

Topiramate Group

EXPERIMENTAL

Patients' initial dose of topiramate 25mg bid, which was titrated over 18 days to 150 mg bid (with flexibility to titrate to 200mg bid) as tolerated.

Drug: Topiramate

Placebo Group

PLACEBO COMPARATOR

Sugar pill

Drug: Placebo

Interventions

Topiramate DRUG

Oral topiramate 300-400mg/day for 12 weeks

Also known as: Topamax

Topiramate Group

Placebo DRUG

Matched placebo to Experimental arm

Also known as: Sugar pill

Placebo Group

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Male or female patients, ages 10-18 years.
• Female patients of menarche must be using a medically accepted means of contraception (e.g. oral contraceptives, Depo-Provera, abstinence).
• Each patient's authorized legal guardian must understand the nature of the study and must provide written informed consent. Each patient must also give assent to study participation.
• Patients must have a diagnosis of Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV-TR) bipolar disorder, type I and currently display an acute manic or mixed episode as determined by K-SADS (Geller et al 2000).
• Patients must have a baseline (day 0) Young Mania Rating Scale score of at least 16.
• Subjects should be fluent in English.

You may not qualify if:

• Female patients who are either pregnant or lactating.
• Clinically significant or unstable hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, immunologic, hematologic or other systemic medical conditions.
• Any history of current or past diabetes that has been treated with pharmacological intervention.
• Neurological disorders including epilepsy, stroke, or severe head trauma.
• Clinically significant laboratory abnormalities (\> 3 times upper limit of normal), on any of the following tests: CBC with differential, electrolytes, BUN, creatinine, hepatic transaminases, lipid profile, fasting glucose, urinalysis, or thyroid indices. Clinically abnormal ECG.
• Manic or mixed episode due to a general medical condition or substance-induced mania (DSM-IV-TR).
• Mental retardation (IQ \<70).
• History of hypersensitivity to or intolerance of olanzapine or topiramate.
• Prior history of olanzapine or topiramate non-response or allergic reaction.
• DSM-IV substance (except nicotine or caffeine) dependence within the past 3 months.
• Judged clinically to be at suicidal risk (defined as having active suicidal ideation, intent or plan, or a serious suicide attempt within 30 days, or a baseline Children's Depression Rating Scale suicide score of \>3).
• Treatment with an injectable depot neuroleptic within less than one dosing interval between depot neuroleptic injections and day 0.
• Treatment with concurrent mood stabilizers or anticonvulsants, benzodiazepines (except as described below), psychostimulants, guanethidine, or guanadrel, or antidepressants.
• Schizophrenia or other psychotic disorders (including schizophreniform disorder, schizoaffective disorder, delusional disorder, brief psychotic disorder, shared psychotic disorder, psychotic disorder due to a general medical condition, substance-induced psychotic disorder, psychotic disorder not otherwise specified) as defined in the DSM-IV.
• Major depressive disorder, dysthymic disorder, depressive disorder not otherwise specified.

Sponsors & Collaborators

• University of Cincinnati: lead
• Eli Lilly and Company: collaborator

Study Sites (1)

University of Cincinnati Medical Center

Cincinnati, Ohio, 45267-0559, United States

Location

Related Publications (1)

• DelBello MP, Bruns KM, Bloom T, Patino Duran LR, Strawn J, Adler CM, Welge J. A Double-Blind Placebo-Controlled Pilot Study of Topiramate in Manic Adolescents Treated with Olanzapine. J Child Adolesc Psychopharmacol. 2023 May;33(4):126-133. doi: 10.1089/cap.2022.0098. Epub 2023 May 2.

  PMID: 37130314 DERIVED

MeSH Terms

Conditions

Bipolar Disorder; Weight Gain

Interventions

Topiramate; Sugars

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fructose; Hexoses; Monosaccharides; Carbohydrates; Ketoses

Results Point of Contact

• Title: Melissa DelBello, MD
• Organization: University of Cincinnati

melissa.delbello@uc.edu

513-558-4489

Study Officials

• Melissa P DelBello, MD

  University of Cincinnati

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 27, 2006
• First Posted: October 31, 2006
• Study Start: December 1, 2006
• Primary Completion: August 1, 2009
• Study Completion: September 1, 2009
• Last Updated: April 9, 2025
• Results First Posted: April 4, 2013

Record last verified: 2025-03

Locations

US (1)